At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Identifying Neurophysiological Mechanisms of Susceptibility to Estradiol Fluctuation and Irritability Symptoms in the Menopause Transition: An Experimental Approach
In Brief
A Phase 4 clinical trial evaluating Estradiol Patch, 0.1 mg/24 Hours Weekly Transdermal Film, Extended Release, Placebo, and 1 other intervention for Menopause and Irritable Mood. Completed, enrolled 40 participants across 1 site.
Detailed Summary
Women in the menopause transition (perimenopause) experience substantial day-to-day variability in estradiol and have a 2-4-fold increase in major depression risk. About 40% of perimenopausal women are susceptible to the emergence of affective symptoms tied to changes in estradiol. Among the perimenopausal women with affective impairment, most report irritability, not "depression," is their primary source of impairment and distress. The purpose of this research is to determine the neurophysiologic basis of susceptibility to estradiol fluctuations and irritability symptoms in perimenopausal women.
Study Details
Timeline
Interventions
0.1 mg/day transdermal patch administered for 3 weeks
Estradiol-matched placebo patch administered for 3 weeks
200 mg tablet administered by mouth once per day for 10 days after completion of the experimental phase of the study